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Completed

NCT Number: NCT01825486

Balance and Gait Characteristics to Predict Accidental Falls in Community-dwelling Stroke Elderly

Background: Accidental falls result in major physical and psychological morbidity in the elderly, especially stroke patients. To get optimal prevention of stroke falls, it is crucial to identify independent risk factors from multivariate analysis of related balance and gait parameters.

Aim: To evaluate the effects of balance and gait characteristics in determining whether or not accidental falls may happen. To investigate if the balance and gait parameters affect the time from lesion to when (and if) patients suffer from falls. To compare differences of balance and gait parameters in accidental fall patients between those with severe accidental injuries and those without severe injuries.

Methods: The 2-year observational cohort study will enroll 706 elderly stroke patients, who have not had a previous stroke. They will be retrieved from the Inpatient department and followed-up regularly in the Outpatient department when they are discharged. All subjects will be evaluated at 1 month and 6 months after stroke. These evaluations will include: mental, cognition and depression status; lower-limb muscle strength assessed by a dynamometer as well as range of motion of joints assessed by a biaxial electro-goniometry; functional independence measure; balance and gait pattern will be assessed by both clinical observation and objective laboratory examination (a dynamic posturography and computerized gait analysis system); falls and fall-related injuries during the proceeding year. Differences in baseline characteristics are tested by one-way ANOVA, Mann Whitney U or t tests, if appropriate. The investigators will identify the independent risk factors of accidental falls with logistic regression and use the log rank statistic of Kaplan-Meier survival curve to differentiate the risk of accidental falls or fall-related injuries in different groups.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhua Christian Hospital Taiwan

Changhua, 500, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age>65
  • confirmed stroke by CT or MRI
  • first-ever stroke
  • with walking ability after stroke onset 1 month

Exclusion criteria

  • fall history before stroke
  • living in nursing home
  • unstable physical sign
  • seizure attack during study
  • impaired cognition

Treatment and study plan

accidental falls

Behavioral

Primary outcomes

  1. Computerized balance evaluation

    Time frame: 1 month after the first stroke

    computerized balance and gait evaluation by a posturography and gait analysis system

Secondary outcomes

  1. Geriatric Depression Scale

    Time frame: 1 month after the first stroke

    Geriatric Depression Scale to measure depression

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Apr 5, 2013
Registry last updated
Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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